Evaluation of a pen device for self-administration of recombinant human FSH in clomiphene citrate-resistant anovulatory women undergoing ovulation induction

Abstract

This open-label multicentre study evaluated ease of use, safety, and efficacy of a pen device for self-administration of recombinant follicle-stimulating hormone (rFSH) in 43 subjects undergoing ovulation induction. Follitropin beta was administered subcutaneously with the Follistim Pen within 3 days of onset of menses. A 75 IU starting dose could be increased by 25 or 50 IU on days 8 and 15 if no ovarian response was observed. Human chorionic gonadotrophin (HCG; 10,000 IU) was administered when one follicle > or =18 mm or two to three follicles > or =15 mm were observed. Subjects received standardized instruction for the pen device and subject comprehension was recorded as subjects practised and prepared injections. Ease of use was also evaluated by questionnaire. Forty-four subjects enrolled; 43 were treated with rFSH and 41 were treated with HCG. The comprehension questionnaire revealed that during the mock injection, 100% of subjects properly loaded the cartridge into the pen device, while 95% selected the correct dose and 100% self-injected the medication prescribed. During the second actual injection, 100% of subjects comprehended these pen-related steps. The ease-of-use questionnaire showed that 100% of the subjects rated the overall experience of self-administering with the pen as 'very good' to 'good'. Mean duration and total amount of follitropin beta were 11.4 +/- 4.2 days and 1070.3 +/- 580.3 IU respectively. Ovulation rate was 95%. Biochemical and ongoing pregnancy rates per attempt were 34.9 and 30.2% respectively. Three subjects experienced serious adverse events [asthma; ovarian hyperstimulation syndrome (OHSS) and pain; OHSS]. In conclusion, the pen device provides an easy, safe, and effective way for women to self-administer follitropin beta during ovarian stimulation.

Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens

“…The Puregon* pen, introduced 5 years ago, is a reusable device supplied with cartridges of r-hFSH (follitropin beta) solution. It is considered easy to use 18,19 , and has been shown to be a more convenient and less painful method of administration compared with conventional syringes and vials 20,21 .…”

A comparison of the efficacy, tolerability, and convenience of two formulations of follitropin-α in Iranian woman undergoing intracytoplasmic sperm injection cycles

“…In two separate studies, Kettel et al (11) showed 100% and Pang et al (6) showed 98.3% of subjects rated their overall experience of self-administrating follitropin-b with the pen device as ''very good'' to ''good.'' Overall convenience in this study was high, but there was no statistically significant difference between two groups (P¼.248).…”

Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women

“…Each question used a qualitative scale, such as 'very', 'somewhat', 'not at all', 'not applicable', according to the specific question asked (Appendix A). The 14-question assessment was similar to those used to assess diabetic patient experience with insulin pen devices 9-12,17 and another gonadotropin pen device 13,14 . On stimulation day 6, patients were asked to complete an in-treatment questionnaire evaluating their experiences to date with the follitropin alfa prefilled pen (Appendix B).…”

“…The study follows several previous open-label, multicenter investigations which examined patient experience with a pen device for gonadotropin administration 13,14 . Although non-comparative, the studies by Pang et al 13 and Kettel et al 14 device easy to use for the administration of follitropin beta.…”

“…Although non-comparative, the studies by Pang et al 13 and Kettel et al 14 device easy to use for the administration of follitropin beta. In contrast to these studies, we asked patients to assess their prior experience (within the past 6 months) with traditional gonadotropin injection methods (vials/ ampoules and syringe) prior to initiating treatment with the follitropin alfa prefilled pen.…”